NCT03326973已完成不适用
Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- total score of Global QOL overall health index
研究概览
简要总结
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to speak and read English
- •Be able to provide informed consent
- •Have been diagnosed with metastatic melanoma at age 18 years or older
- •Have been treated with either single agent or combination checkpoint inhibitor
- •Be at least 12 months since first dose of above named agents
- •Received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist)
排除标准
- •Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team
- •Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers
- •Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record
- •Patients with symptomatic progression but continue on immunotherapy
- •Note: For any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist
结局指标
主要结局
total score of Global QOL overall health index
时间窗: 1 year
On the EQ-5D-3L, respondents are asked to indicate their health state by marking the box associated with the most appropriate statement in each of the 5 dimensions, resulting in a one digit number expressing the level (1-3) selected for that dimension from no problems to extreme problems.
次要结局
未报告次要终点
研究者
研究点 (6)
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